Olmesartan Medoxomil in Hypertension and Renal Impairment

Official Title: “Efficacy and Safety of Olmesartan Medoxomil Compared With Losartan in Patients With Hypertension and Mild to Moderate Renal Impairment”

This is a study in hypertensive patients with mild to moderate renal impairment. The antihypertensive efficacy of olmesartan medoxomil is compared to losartan.

Intervention(s) in this Clinical Trial

• Drug: Olmesartan medoxomil
  • Olmesartan oral tablets 20 or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.
• Drug: Losartan
  • Medications are taken once daily before breakfast with water.
• Drug: Furosemide oral tablets
  • If its use is necessary, the dose of furosemide allowed is 20 to 120 mg per day at the discretion of the investigator

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Olmesartan medoxomil
  • Olmesartan oral tablets 20 mg or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.
• Experimental: Losartan
  • Losartan over encapsulated tablets 50 mg and 100 mg plus olmesartan placebo.

Primary Measures

• Change in mean sitting diastolic blood pressure (dBP), assessed by conventional blood pressure measurements after 12 weeks of treatment
  • Time Frame: Baseline to 12 weeks
    Safety Issue?: No

Secondary Measures

• Change in mean sitting diastolic blood pressure, assessed by conventional blood pressure measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment;
  • Time Frame: Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks
    Safety Issue?: No
• Change in mean sitting systolic blood pressure, assessed by conventional blood pressure measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment;
  • Time Frame: Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks
    Safety Issue?: No
• Response to treatment after 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks of treatment;
  • Time Frame: Baseline to 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks
    Safety Issue?: No
• Changes in creatinine clearance after 12 and 52 weeks of treatment, changes in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment;
  • Time Frame: Baseline to 12 and 52 weeks
    Safety Issue?: No
• Changes in serum creatinine after 12 and 52 weeks of treatment
  • Time Frame: Baseline to 12 and 52 weeks
    Safety Issue?: No
• Rate of patients per dose level after 12 and 52 weeks of treatment
  • Time Frame: Baseline to 12 and 52 weeks
    Safety Issue?: No
• Change in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment
  • Time Frame: Baseline to 4, 12, 24, 36 and 52 weeks
    Safety Issue?: No

Inclusion Criteria:

• Mean sitting BP prior to randomization of 140-180/90-109 mmHg;
• Renal impairment prior to randomization of mild (50 ≤ CLcr ≥ 80 mL/min) to moderate (30 ≤ CLcr ≥50 mL/min) severity

Exclusion Criteria:

• Malignant hypertension or sitting BP greater than 180/109 mmHg;
• Severe heart failure, severe renal disease;
• Recent history of myocardial infarction, stroke or transient ischemic attack;
• History, clinical or current evidence of any significant gastrointestinal, respiratory, hematological, metabolic, immunological or any other underlying disease which in the opinion of the investigator would interfere with the patient's participation in the trial;
• Hypersensitivity or contraindications to ARBs or ACE inhibitors or any cross allergy;
• Treatment with dis-allowed medication;
• Pregnant or breastfeeding females or females of childbearing potential without adequate contraception;
• History of drug and/or alcohol abuse

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Sankyo Pharma Gmbh Industry

Overall Clinical Trial Officials and Contacts

P. U. Witte, MD, PhD Principal Investigator IMFORM GmbH, Darmstadt, Germany  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00151827

Study ID Number: SE-866/43

ClinicalTrials.gov Identifier: NCT00151827

Health Authority: Germany: Federal Institute for Drugs and Medical Devices